Your tasks and responsibilities:
This position will be responsible for collaborating with the China Project Element Team and Element team in Walpole to develop, staff, and execute the transfer plans as well as support activities to ensure plant readiness for product registration, launch, and commercial production.
•Collaborating with the Walpole based Project Technical Transfer group to develop detailed Immunoassay product transfer plans to support product and production registration timelines.
•Supporting activities necessary to prepare for successful transfer of documents, test methods, manufacturing processes, etc.
•Identifying Subject Matter Experts for local element teams needed for successful assay transfer.
•Coordination of assay transfer validation activities for the site.
•Providing input into the creation of a process to coordinate with R&D, Walpole and the China site to ensure that newly developed assays are transferred successfully in the future.
•Other related projects or tasks assigned by superior or company.
Your qualifications and experience:
•3+ years of experience in GMP and CFDA regulated environment, IVD experience is must to have.
•Experience in participate at least 1 NPI/transfer product from transfer to CFDA/Manufacturing license
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai
Experience Level: Experienced Professional
Job Type: Full-time